Transcript CoreValve ® SURTAVI Trial 1 Inclusion Criteria

Medtronic CoreValve®
SURTAVI Trial
SUrgical Replacement and Transcatheter Aortic Valve Implantation
UC201204978b EE
These materials are provided to you strictly for your use in preparing to and participating in the SURTAVI Trial.
CAUTION – Investigational device. Exclusively for Clinical Investigations. . ©Medtronic, Inc. 2013. All Rights Reserved. Non destiné au marché français.
Medtronic TAVI Clinical Research Portfolio
Confirm Efficacy
and Optimize
Practice
Expand Access
to New
Populations
and Markets
Demonstrate
Safety and
Efficacy
These materials are provided to you strictly for your use in preparing to and participating in the SURTAVI Trial.
CAUTION – Investigational device. Exclusively for Clinical Investigations. . ©Medtronic, Inc. 2013. All Rights Reserved. Non destiné au marché français.
Medtronic TAVI Clinical Research Portfolio
• Management of Severe Aortic Stenosis in intermediate
risk patients
• CoreValve SURTAVI Trial
o
o
o
o
Inclusion Criteria
Exclusion Criteria
Study Investigators
Current Status
• Comparisons
o US Pivotal Trial and SURTAVI Trial
o SURTAVI Trial and PARTNER II A
These materials are provided to you strictly for your use in preparing to and participating in the SURTAVI Trial.
CAUTION – Investigational device. Exclusively for Clinical Investigations. . ©Medtronic, Inc. 2013. All Rights Reserved. Non destiné au marché français.
Medtronic TAVI Clinical Research Portfolio
• Management of Severe Aortic Stenosis in intermediate
risk patients
• CoreValve SURTAVI Trial
o
o
o
o
Inclusion Criteria
Exclusion Criteria
Study Investigators
Current Status
• Comparisons
o US Pivotal Trial and SURTAVI Trial
o SURTAVI Trial and PARTNER II A
These materials are provided to you strictly for your use in preparing to and participating in the SURTAVI Trial.
CAUTION – Investigational device. Exclusively for Clinical Investigations. . ©Medtronic, Inc. 2013. All Rights Reserved. Non destiné au marché français.
CoreValve® SURTAVI Trial Overview1
• Randomized 1:1, non-inferiority study
• The trial will be conducted at up to 115 worldwide
centers
• Europe
• Canada
• United States
• Long-term follow-up through 5 years
• Approximately 2,500 subjects
1. Medtronic CoreValve® SURTAVI Trial. Version 6.0. Mounds View, MN: Medtronic, Inc. Clinical Research; 2013.
These materials are provided to you strictly for your use in preparing to and participating in the SURTAVI Trial.
CAUTION – Investigational device. Exclusively for Clinical Investigations. . ©Medtronic, Inc. 2013. All Rights Reserved. Non destiné au marché français.
CoreValve® SURTAVI Trial
Patient Population
• Severe, symptomatic AS
• Intermediate surgical risk, defined by Society of
Thoracic Surgeons (STS) mortality risk of ≥ 4%
and ≤ 10%
These materials are provided to you strictly for your use in preparing to and participating in the SURTAVI Trial.
CAUTION – Investigational device. Exclusively for Clinical Investigations. . ©Medtronic, Inc. 2013. All Rights Reserved. Non destiné au marché français.
CoreValve® SURTAVI Trial
Study Design
STS mortality risk
≥4% and ≤10%
Heart Team Evaluation
Confirm Inclusion/Exclusion &
Intermediate Risk Classification
Randomization
Stratified by need for
revascularization
Baseline
Neurological
Assessments
N = ~2,500 patients
Medtronic
CoreValve® TAVI
TAVI + PCI
TAVI only
SAVR
SAVR + CABG
These materials are provided to you strictly for your use in preparing to and participating in the SURTAVI Trial.
CAUTION – Investigational device. Exclusively for Clinical Investigations. . ©Medtronic, Inc. 2013. All Rights Reserved. Non destiné au marché français.
SAVR only
CoreValve® SURTAVI Trial1
Primary Objective and Endpoint
Primary Objective
Evaluate in a prospective randomized fashion whether
TAVI is non-inferior to SAVR with respect to composite
endpoint of all-cause mortality and disabling stroke at
24 months in patients with symptomatic severe aortic
stenosis and at intermediate surgical risk
Primary Endpoint
All-cause mortality or disabling stroke at 24-months
1. Medtronic CoreValve® SURTAVI Trial. Version 6.0. Mounds View, MN: Medtronic, Inc. Clinical Research; 2013.
These materials are provided to you strictly for your use in preparing to and participating in the SURTAVI Trial.
CAUTION – Investigational device. Exclusively for Clinical Investigations. . ©Medtronic, Inc. 2013. All Rights Reserved. Non destiné au marché français.
CoreValve® SURTAVI Trial1
Secondary Objectives
Secondary Objective
• Assess differences in quality of life, clinical benefit (efficacy
endpoints) and health economics in patients with symptomatic
severe aortic stenosis and at intermediate risk treated with
either Transcatheter Aortic Valve Implantation (TAVI) or Surgical
Aortic Valve Replacement (SAVR)
Exploratory Objective
• An analysis will be conducted to determine if patients can be
identified as intermediate risk for Transcatheter Aortic Valve
Implantation (TAVI) based upon age and the presence of a
defined list of co-morbidities commonly associated with patients
undergoing TAVI procedures
1. Medtronic CoreValve® SURTAVI Trial. Version 6.0. Mounds View, MN: Medtronic, Inc. Clinical Research; 2013.
These materials are provided to you strictly for your use in preparing to and participating in the SURTAVI Trial.
CAUTION – Investigational device. Exclusively for Clinical Investigations. . ©Medtronic, Inc. 2013. All Rights Reserved. Non destiné au marché français.
CoreValve® SURTAVI Trial1
Device and Access Routes
• CoreValve® System
• 23mm, 26mm, 29mm, 31mm
• Alpha-amino oleic acid (AOA®) antimineralization
treatment
• Access Routes
• Transfemoral
• Subclavian
• Direct Aortic
1. Medtronic CoreValve® SURTAVI Trial. Version 6.0. Mounds View, MN: Medtronic, Inc. Clinical Research; 2013.
These materials are provided to you strictly for your use in preparing to and participating in the SURTAVI Trial.
CAUTION – Investigational device. Exclusively for Clinical Investigations. . ©Medtronic, Inc. 2013. All Rights Reserved. Non destiné au marché français.
CoreValve® SURTAVI Trial1
Coronary Artery Disease
• Subjects with CAD and a Syntax score ≤22 will
be eligible
• Concomitant PCI and TAVI can be performed;
staging is left at discretion of operator
• CABG should be conducted during the index SAVR
procedure
• Randomization stratified by need for coronary
revascularization
These materials are provided to you strictly for your use in preparing to and participating in the SURTAVI Trial.
CAUTION – Investigational device. Exclusively for Clinical Investigations. . ©Medtronic, Inc. 2013. All Rights Reserved. Non destiné au marché français.
CoreValve® SURTAVI Trial1
Frailty Assessment
• Frailty assessments identifies:
– Subject is < 80 years of age and three or more of the following
apply
– Subject is ≥ 80 years of age and two or more of the following
apply
• Wheelchair bound
• Resides in an institutional care facility (e.g. nursing home,
skilled care center)
• Body Mass Index < 20 kg/m2
• Grip strength < 16kg
• Katz Index Score ≤ 4
• Albumin < 3.5 g/dl
1. Medtronic CoreValve® SURTAVI Trial. Version 6.0. Mounds View, MN: Medtronic, Inc. Clinical Research; 2013.
These materials are provided to you strictly for your use in preparing to and participating in the SURTAVI Trial.
CAUTION – Investigational device. Exclusively for Clinical Investigations. . ©Medtronic, Inc. 2013. All Rights Reserved. Non destiné au marché français.
Medtronic TAVI Clinical Research Portfolio
• Management of Severe Aortic Stenosis in intermediate
risk patients
• CoreValve SURTAVI Trial
o
o
o
o
Inclusion Criteria
Exclusion Criteria
Study Investigators
Current Status
• Comparisons
o US Pivotal Trial and SURTAVI Trial
o SURTAVI Trial and PARTNER II A
These materials are provided to you strictly for your use in preparing to and participating in the SURTAVI Trial.
CAUTION – Investigational device. Exclusively for Clinical Investigations. . ©Medtronic, Inc. 2013. All Rights Reserved. Non destiné au marché français.
CoreValve® SURTAVI Trial1
Inclusion Criteria
1. Subject must have STS mortality risk score of ≥ 4%
and ≤ 10%
2. Heart Team consisting of at least one interventional
cardiologist and one cardiac surgeon agree on
indication, treatment proposal, and eligibility for
randomization based on their clinical judgment
1. Medtronic CoreValve® SURTAVI Trial. Version 6.0. Mounds View, MN: Medtronic, Inc. Clinical Research; 2013.
These materials are provided to you strictly for your use in preparing to and participating in the SURTAVI Trial.
CAUTION – Investigational device. Exclusively for Clinical Investigations. . ©Medtronic, Inc. 2013. All Rights Reserved. Non destiné au marché français.
CoreValve® SURTAVI Trial1
Inclusion Criteria (cont.)
3. Subject has severe aortic valve stenosis presenting with:
a) Critical aortic valve area defined as an initial aortic
valve area of ≤1.0 cm2 or aortic valve area index < 0.6
cm2/m2
AND
b) Mean gradient > 40mmHg or Vmax > 4.0m/sec by
resting echocardiogram [or dobutamine stress
echocardiogram, if subject has a left ventricular ejection
fraction (LVEF) <55%] or velocity ratio < 0.25
4. Subject is symptomatic from his/her aortic valve stenosis, as
demonstrated by New York Heart Association (NYHA)
Functional Class II or greater
1. Medtronic CoreValve® SURTAVI Trial. Version 6.0. Mounds View, MN: Medtronic, Inc. Clinical Research; 2013.
These materials are provided to you strictly for your use in preparing to and participating in the SURTAVI Trial.
CAUTION – Investigational device. Exclusively for Clinical Investigations. . ©Medtronic, Inc. 2013. All Rights Reserved. Non destiné au marché français.
CoreValve® SURTAVI Trial1
Inclusion Criteria (cont.)
5. Subject and the treating physician agree that the
subject will return for all required post-procedure
follow-up visits
6. Subject meets the legal minimum age to provide
informed consent based on local regulatory
requirements
1. Medtronic CoreValve® SURTAVI Trial. Version 6.0. Mounds View, MN: Medtronic, Inc. Clinical Research; 2013.
These materials are provided to you strictly for your use in preparing to and participating in the SURTAVI Trial.
CAUTION – Investigational device. Exclusively for Clinical Investigations. . ©Medtronic, Inc. 2013. All Rights Reserved. Non destiné au marché français.
Medtronic TAVI Clinical Research Portfolio
• Management of Severe Aortic Stenosis in intermediate
risk patients
• CoreValve SURTAVI Trial
o
o
o
o
Inclusion Criteria
Exclusion Criteria
Study Investigators
Current Status
• Comparisons
o US Pivotal Trial and SURTAVI Trial
o SURTAVI Trial and PARTNER II A
These materials are provided to you strictly for your use in preparing to and participating in the SURTAVI Trial.
CAUTION – Investigational device. Exclusively for Clinical Investigations. . ©Medtronic, Inc. 2013. All Rights Reserved. Non destiné au marché français.
CoreValve® SURTAVI Trial1
Key Exclusion Criteria
• Subject has refused surgical aortic valve replacement
(SAVR) as a treatment option
• Multivessel coronary artery disease with a Syntax score
>22
• Extensive mediastinal radiation
• Liver failure (Child-C)
1. Medtronic CoreValve® SURTAVI Trial. Version 6.0. Mounds View, MN: Medtronic, Inc. Clinical Research; 2013.
These materials are provided to you strictly for your use in preparing to and participating in the SURTAVI Trial.
CAUTION – Investigational device. Exclusively for Clinical Investigations. . ©Medtronic, Inc. 2013. All Rights Reserved. Non destiné au marché français.
CoreValve® SURTAVI Trial1
Key Exclusion Criteria1 (cont.)
• Reduced ventricular function with left ventricular
ejection fraction (LVEF) <20% as measured by resting
echocardiogram
• Pulmonary Hypertension > 80mmHg
• Severe Chronic Obstructive Pulmonary Disease
(COPD) demonstrated by Forced Expiratory Volume
(FEV1) < 750cc
1. Medtronic CoreValve® SURTAVI Trial. Version 6.0. Mounds View, MN: Medtronic, Inc. Clinical Research; 2013.
These materials are provided to you strictly for your use in preparing to and participating in the SURTAVI Trial.
CAUTION – Investigational device. Exclusively for Clinical Investigations. . ©Medtronic, Inc. 2013. All Rights Reserved. Non destiné au marché français.
Medtronic TAVI Clinical Research Portfolio
• Management of Severe Aortic Stenosis in intermediate
risk patients
• CoreValve SURTAVI Trial
o
o
o
o
Inclusion Criteria
Exclusion Criteria
Study Investigators
Current Status
• Comparisons
o US Pivotal Trial and SURTAVI Trial
o SURTAVI Trial and PARTNER II A
These materials are provided to you strictly for your use in preparing to and participating in the SURTAVI Trial.
CAUTION – Investigational device. Exclusively for Clinical Investigations. . ©Medtronic, Inc. 2013. All Rights Reserved. Non destiné au marché français.
CoreValve® SURTAVI Trial
Study Investigators
Chairman
Prof. P.W. Serruys (Chair)
Dr. N. Van Mieghem (Deputy Chair)
Principal Investigators
Prof. S. Windecker
Dr. J. Popma
Prof. A.P. Kappetein
Dr. D. Adams
Prof. R. Lange
Dr. M. Reardon
Prof. T. Walther
These materials are provided to you strictly for your use in preparing to and participating in the SURTAVI Trial.
CAUTION – Investigational device. Exclusively for Clinical Investigations. . ©Medtronic, Inc. 2013. All Rights Reserved. Non destiné au marché français.
Medtronic TAVI Clinical Research Portfolio
• Management of Severe Aortic Stenosis in intermediate
risk patients
• CoreValve SURTAVI Trial
o
o
o
o
Inclusion Criteria
Exclusion Criteria
Study Investigators
Current Status
• Comparisons
o US Pivotal Trial and SURTAVI Trial
o SURTAVI Trial and PARTNER II A
These materials are provided to you strictly for your use in preparing to and participating in the SURTAVI Trial.
CAUTION – Investigational device. Exclusively for Clinical Investigations. . ©Medtronic, Inc. 2013. All Rights Reserved. Non destiné au marché français.
CoreValve ® SURTAVI Trial
US Clinical Sites
Active Site
These materials are provided to you strictly for your use in preparing to and participating in the SURTAVI Trial.
CAUTION – Investigational device. Exclusively for Clinical Investigations. . ©Medtronic, Inc. 2013. All Rights Reserved. Non destiné au marché français.
CoreValve ® SURTAVI Trial
US Clinical Sites - Activated
1
Beth Israel Deaconess Medical Center
Boston, MA
7
Pinnacle Health
Harrisburg, PA
2
Duke University Medical Center
Durham, NC
8
Riverside Methodist Hospital/
Ohio Health Research Institute
Columbus, OH
3
Geisinger Medical Center
Danville, PA
9
Spectrum Health Hospitals
Grand Rapids, MI
4
Iowa Heart Center
Des Moines, IA
10
St. Francis Hospital
Roslyn, NY
5
Johns Hopkins Hospital
Baltimore, MD
11
St John Hospital and Medical Center
Detroit, MI
6
Morristown Memorial Hospital
Morristown, NJ
12
St. Luke's Medical Center/
Aurora Health Care
Milwaukee, WI
These materials are provided to you strictly for your use in preparing to and participating in the SURTAVI Trial.
CAUTION – Investigational device. Exclusively for Clinical Investigations. . ©Medtronic, Inc. 2013. All Rights Reserved. Non destiné au marché français.
CoreValve ® SURTAVI Trial
US Clinical Sites - Activated (cont.)
13
The Mount Sinai Medical Center
New York, NY
21
Baylor Heart & Vascular
Dallas, TX
14
The Ohio State University Medical Center/The
Richard M. Ross Heart Hospital
Columbus, OH
22
Hartford Hospital
Hartford, CT
23
University of Kansas Hospital
Kansas City, KS
Methodist DeBakey Heart & Vascular
Houston, TX
24
University of Michigan Health Systems
Ann Arbor, MI
University Hospital/Case Medical Center
Cleveland, OH
25
University of Pittsburgh Medical Center
Pittsburgh, PA
Detroit Medical Center
Detroit, MI
26
University of Southern California
Los Angeles, CA
North Shore University Hospital
Manhasset, NY
27
Loyola University Medical Center
Maywood, IL
Vanderbilt University Medical Center
Nashville, TN
28
Cardiovascular Institute of the South
Houma, LA
29
VA Palo Alto
Palo Alto, CA
15
16
17
18
19
20
Wake Forest University/
Baptist Medical Center
Winston-Salem, NC
These materials are provided to you strictly for your use in preparing to and participating in the SURTAVI Trial.
CAUTION – Investigational device. Exclusively for Clinical Investigations. . ©Medtronic, Inc. 2013. All Rights Reserved. Non destiné au marché français.
CoreValve ® SURTAVI Trial
US Clinical Sites – Activated (cont.)
30
Fletcher Allen Health Care
Burlington, VT
38
Scripps Green Health
La Jolla, CA
31
NYU-Langone Medical Center
New York, NY
39
Washington Hospital Center
Washington, DC
32
El Camino Hospital
Mountain View, CA
40
Columbia University Medical Center
New York, NY
33
Kaiser Permanente
Los Angeles, CA
41
Good Samaritan Hospital
Cincinnati, OH
34
Lenox Hill Hospital
New York, NY
35
University of Miami
Miami, FL
36
Yale New Haven Hospital
New Haven, CT
37
Piedmont Heart Institute
Atlanta, GA
These materials are provided to you strictly for your use in preparing to and participating in the SURTAVI Trial.
CAUTION – Investigational device. Exclusively for Clinical Investigations. . ©Medtronic, Inc. 2013. All Rights Reserved. Non destiné au marché français.
CoreValve ® SURTAVI Trial
European Clinical Sites
13
5
3
10
11
1 4
12 6 15
14
27
8
These materials are provided to you strictly for your use in preparing to and participating in the SURTAVI Trial.
CAUTION – Investigational device. Exclusively for Clinical Investigations. . ©Medtronic, Inc. 2013. All Rights Reserved. Non destiné au marché français.
CoreValve ® SURTAVI Trial
European Clinical Sites - Activated
1
Erasmus Medical Center
Rotterdam, Netherlands
2
Inselspital - Universitatsspital Bern
Bern, Switzerland
3
4
Leeds General Infirmary
Leeds, UK
Righospitalet
Copenhagen, Denmark
6
St. Antonius Ziekenhuis
Nieuwegein, Netherlands
7
Universitatsspital Zurich
Zurich, Switzerland
9
St. George’s Hospital
London, UK
10
11
Royal Sussex County Hospital
Brighton, UK
12
Medisch Centrum Leeuwarden
Leeuwarden, Netherlands
5
8
10
Amphia Hospital
Breda, Netherlands
13
Karolinska University Hospital
Stockholm, Sweden
10
14
German Heart Center
Munich, Germany
15
University Hospital
Bonn, Germany
Hospital Universitario Central de Asturias
Oviedo, Spain
Hospital Universitario Virgen de la Victoria
Malaga, Spain
These materials are provided to you strictly for your use in preparing to and participating in the SURTAVI Trial.
CAUTION – Investigational device. Exclusively for Clinical Investigations. . ©Medtronic, Inc. 2013. All Rights Reserved. Non destiné au marché français.
CoreValve ® SURTAVI Trial
Canadian Clinical Sites
1
Montreal Heart Institute
Montreal, Quebec
2
Royal Victoria
Montreal, Quebec
3
University of Ottawa Heart Institute
Ottawa, Ontario
4
London Health Sciences Center/
University Hospital
London, Ontario
5
Toronto General Hospital
Toronto, Ontario
3 21
5
4
These materials are provided to you strictly for your use in preparing to and participating in the SURTAVI Trial.
CAUTION – Investigational device. Exclusively for Clinical Investigations. . ©Medtronic, Inc. 2013. All Rights Reserved. Non destiné au marché français.
Medtronic TAVI Clinical Research Portfolio
• Management of Severe Aortic Stenosis in intermediate
risk patients
• CoreValve SURTAVI Trial
o
o
o
o
Inclusion Criteria
Exclusion Criteria
Study Investigators
Current Status
• Comparisons
o US Pivotal Trial and SURTAVI Trial
o SURTAVI Trial and PARTNER II A
These materials are provided to you strictly for your use in preparing to and participating in the SURTAVI Trial.
CAUTION – Investigational device. Exclusively for Clinical Investigations. . ©Medtronic, Inc. 2013. All Rights Reserved. Non destiné au marché français.
Comparison
SURTAVI Trial and US Pivotal Trial
SURTAVI
US Pivotal
Extreme Risk
US Pivotal
High Risk
Patient Population
Symptomatic severe AS at
intermediate surgical risk: STS
mortality risk of ≥4% and ≤10%
Symptomatic severe AS, with
predicted operative mortality or
serious, irreversible morbidity risk
of ≥ 50% at 30 days.
Symptomatic severe AS, with
predicted risk of operative mortality
is ≥15% (and predicted operative
mortality or serious, irreversible
morbidity risk of < 50%) at 30 days.
Concomitant Coronary
Revascularization
Sample Size
Allowed
Excluded
Excluded
~ 2,500 (adaptive design)
1597 (including High Risk)
1597 (including Extreme Risk)
Geography
US, Europe, Canada
US
US
# of Worldwide Sites
115
45
45
Definition of
Severe AS
Initial AVA of ≤1.0 cm2 or AVA index Initial AVA of ≤ 0.8 cm2 (or AVA
< 0.6 cm2/m2
index ≤ 0.5 cm2/m2)
Initial AVA of ≤ 0.8 cm2 (or AVA
index ≤ 0.5 cm2/m2)
Primary Endpoint
All-cause mortality or disabling
stroke at 24 months
Required in primary protocol
All-cause mortality at 12 months
Neuro Sub-Study
Key Exclusion Criteria
Differences
All-cause death or major
stroke at 12 months
Separate sub-study
True Porcelain Aorta; Extensive
Mediastinal Radiation; Liver failure
(Child –C); Frailty Assessments;
Marfan Syndrome; Uncontrolled
AF; Pulmonary HTN; Severe COPD
These materials are provided to you strictly for your use in preparing to and participating in the SURTAVI Trial.
CAUTION – Investigational device. Exclusively for Clinical Investigations. . ©Medtronic, Inc. 2013. All Rights Reserved. Non destiné au marché français.
Separate sub-study
Comparison
SURTAVI Trial and PARTNER II A
SURTAVI
PARTNER II A
≥4 and ≤ 10
STS Inclusion
≥4
>22
Syntax Exclusion
>32
AVA ≤ 1.0cm2
Indexed AVA < 0.6 cm2/m2
Valve Area Inclusion
AVA ≤ 0.8cm2
Indexed EOA < 0.5cm2/m2
Discharge, 30 days,
3 months, 6 months,
12 months, 18 months,
24 months, annually for
5 years
Follow-up Visits
Discharge, 30 days,
6 months, 1 year, annually for
5 years
Global (US, Europe, Canada)
up to 115 centers
Geography
United States and Canada (2)
(57 centers total)
These materials are provided to you strictly for your use in preparing to and participating in the SURTAVI Trial.
CAUTION – Investigational device. Exclusively for Clinical Investigations. . ©Medtronic, Inc. 2013. All Rights Reserved. Non destiné au marché français.
CoreValve® is a registered trademark of Medtronic CV Luxembourg S.a.r.l.
These materials are provided to you strictly for your use in preparing to and participating in the SURTAVI Trial.
CAUTION – Investigational device. Exclusively for Clinical Investigations. . ©Medtronic, Inc. 2013. All Rights Reserved. Non destiné au marché français.